Monday, September 29, 2008

Science Sins and Media Mistakes
What You Should Know About Dietary Supplement News Reporting
By Neil E. Levin, CCN, DANLA
Are male smokers taking beta-carotene really at increased risk of cancer? Are high dosages of Vitamin E really hazardous to your health? Is ephedra, an herb with demonstrated weight loss benefits, really a “killer” that merits its banned status by the U.S. Food and Drug Administration?
Natural health remedies have a long history of promoting health and wellness, dating back thousands of years. But sloppy science and sensationalist health reporting by the news media make this increasingly hard to believe. And misleading and contradictory information about the safety of nutritional supplements may cause consumers to make poor health choices – or to avoid making any choices at all. The result: Many miss out on the myriad health benefits supplementation can bring about. Understanding the common sins of commission and omission on the part of science and the press arms the public with the ability to make better decisions – if not to apply a liberal grain of sea salt to what they’re reading and seeing.
Beta Carotene: Myth vs. Fact
There have been several instances where the reputation of a dietary supplement or herb has been tarnished due to poor science combined with the media’s inertia. The association of cancer risk with the use of the anti-oxidant beta-carotene is a prime example.
In 1994, an antioxidant study being conducted in Finland was halted as a result of a report noting an increase in cancer rates among male smokers taking beta-carotene. Headlines roared: Beta-carotene connected with cancer risk. Doctors told patients to avoid this nutrient and sales dropped.
Yet ten years later, the data was re-analyzed, this time taking into the account the smoker’s total antioxidant intake – not just beta-carotene. The results were clear: a combination of antioxidants – including beta-carotene – actually lowered lung cancer risk in male smokers. Supplementing beta-carotene to people with low antioxidant status was simply a matter of too little, too late. The antioxidant itself was not to blame; the lack of other antioxidants was.
Science Sin:
Poor science did not originally eliminate additional dietary antioxidants as variables or look at how antioxidants interact and support each other. Adding one antioxidant does not make up for the lack of others. Nutrients are not drugs, and supplementing a single nutrient is actually a model of a drug study, not a nutrient study.
Media Mistake: Failing to fact check.
In the original report, the researchers stated that the slightly increased risk was possibly due to chance and that there was no known mechanism as to how this could happen. Yet the news media and others, including a National Institute of Health (NIH) scientific panel, stubbornly continue to refer to beta-carotene as potentially harmful even though credible scientists actually revised those findings years ago and high blood levels of beta-carotene are shown to be consistently protective to populations at risk for cancer.
Sloppy Science and Vitamin E
One of the strongest examples of sloppy science is the controversy over Vitamin E. In 2004, warnings were issued by authors of a study published in Annals of Internal Medicine about taking 400 IU or more of Vitamin E per day. This warning was based on a “meta-analysis” report that was generated by statisticians who mathematically integrated the results collected from 19 individual studies, selected partly on the basis of at least ten deaths occurring - from any cause - in the course of each study. Sales of this essential vitamin dropped dramatically. This was a major national news event.
But when leading antioxidant researchers re-reviewed the same individual datasets more carefully for the American Journal of Clinical Nutrition, they found that daily doses of Vitamin E up to 2,000 IU were actually safe in the same study populations. It seems that the Annals report did not properly segregate doses and forms, such as taking into account other supplements taken. Nor did it find a dose-dependent relationship between vitamin E and death risk, which is a normal toxicological rationale for determining risk. Apparently, it was simply sloppy work that was not able to be replicated using more accurate statistical models that properly accounted for more variables.
Similarly, the Institute of Medicine sets the safe upper level of Vitamin E at 1,500 IU per day. And a recent SENECA study of 90,000 nurses showed a 30% to 40% lower incidence of heart disease among those who take in the highest amounts of Vitamin E from diet and supplements, indicating that the Annals report may have scared a lot of people from taking a life-saving essential vitamin.
Science Sin: Mistaking unverified statistics for proven science.
The straight mathematical integration of data from different selected scientific studies – and the interpretation of the results – were left largely to statisticians whose methods were heavily criticized in comments by other researchers published by the same journal. Consequently, apples were compared
to oranges and the reputation of Vitamin E among consumers continues to feel the squeeze. The researchers have never adequately addressed the criticism or the reanalysis that produced vastly different results.
Media Mistake: Making a mountain out of a molehill.
The outcome of the original study was interpreted by the press to be more meaningful than it really was, as if one study negated all others, and no follow-up was done to report the reanalysis or to mention the myriad of studies showing the proven protective effects of vitamin E. To this day, journalists continue to cite the flawed report – even though Vitamin E has been proven safe and beneficial.
Ephedra’s Bad Rap
But it’s Ephedra – an herb most commonly used to assist with gentle weight loss and easing breathing difficulties – that will go down in history as the most pilloried dietary supplement ever. The FDA banned Ephedra in 2004 based on a series of unproven Adverse Event Reports (AERs.)
AERs are by definition preliminary, unscreened and unverified reports of possible associations of a substance with a side effect. In banning Ephedra, the FDA said that evidence proving that the product has caused actual harm to someone is not required; all that is required is scientific evidence that supports the existence of some theoretical risk.
Ironically, after closer examination of the claims, the FDA eliminated virtually all of the Ephedra AERs from consideration. It also admitted that a total ban on the herb would possibly prevent only one estimated death per year out of 3 billion doses taken by 20 million consumers. In comparison, about 100 out of 11 million people with true food allergies die each year. Yet tree nuts, fish and dairy (the most common food allergens) are still legal.
Science Sin: Considering AERs to behard evidence.
AERs are unverified and thus cannot be considered scientific evidence as proof of toxicity. Government and medical authorities falsely and cynically assumed that most dietary supplement AERs are true, while drugs that have received far more numerous AERs outlining severe side effects (including death) continue to be widely prescribed. More than 100 years of scientific studies were arbitrarily ignored by the FDA in ruling that ephedra had no benefits and no safe level of use; and the agency likewise ignored its own scientific panels that found no smoking gun. Supplements containing large doses of caffeine and other stimulants were lumped in as “ephedra-related” AERs because they also happened to contain ephedra; or more likely, synthetic ephedra alkaloids. Ironically, ephedrine alkaloids are still universally available as OTC drugs for allergies in doses considered too dangerous to sell in a dietary supplement label. However, they are usually sold behind the counter at pharmacies because of the risk of people making crystal meth from these drugs. Ironically, the ephedra herb is too dilute to economically make meth from. I assume that ephedra was axed as an innocent bystander in the drug war to avoid it competing with products which had to be locked up behind the counter. The coincidental timing of the supplement ban and access to the competing drug is very suspicious.
Media Mistake: Not getting the whole story; scaring people unnecessarily.
Journalists did not bother to research the whole story when it when it came to reporting on this controversial herb. The media made the all-too common assumption that press releases issued by researchers or governmental offices are true. With a little digging, the “real” story might have been reported. But the media was largely content to focus on the sensational “killer herb” rather than to investigate the facts and find out the truth.
When controversy arises around dietary supplement or herb, an unproven AER is often at its root. AERs are intended to be an early warning system to allow experts to try to look for and hopefully isolate a dose-related cause and effect. But most, if not all, AERs involving dietary supplements actually involve a combination of substances and issues that include the supplement as well as prescription drugs or other substances along with pre-existing conditions. And many “adverse effects” attributed to supplements are known side effects of prescription drugs.
It’s dubious that either science or the media will admit fault or repent. But with a little effort, consumers can get the most accurate and up-to-date information to ensure they can make informed and beneficial decisions when it comes to their most important asset: our families’ health.

Tuesday, September 09, 2008

Neil contributed Chapter Two of the technical book "Tocotrienols: Vitamin E Beyond Tocopherols" by the American Oil Chemists Society (AOCS), with help from a colleague to format my lecture notes into a book chapter format. That chapter is titled, "Tocotrienols in Vitamin E: Hype or Science?"
2008. Hardbound. 423 Pages.
$155 SRP
CRC Press, Taylor & Francis Group
"This volume goes far beyond the usual considerations of vitamin E to focus on tocotrienols, which, along with tocopherols constitute the bioactive ingredients of vitamin E. Recognized as potent antioxidants, tocotrienols are associated with cholesterol reduction, tumor suppression, and protecting the heart against oxidative stress. Compiling contributions from leading researchers, this book builds upon a recent symposium sponsored by the AOCS. It examines sources, discusses isolation, and delves into the biochemistry and chemistry of tocotrienols. The book then takes a comprehensive look at their role in health and disease, with a special focus on heart disease."
ISBN: 978-1-420080-37-7
https://www.aocs.org/catalog/product.asp?ID=w225&dept=10

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About Me

Neil E. Levin, CCN, DANLA is a nationally board-certified clinical nutritionist with a Diplomate in Advanced Nutritional Laboratory Assessment. He is a professional member of the International & American Associations of Clinical Nutritionists.
Neil is a nutrition educator and a dietary supplement formulator.
Neil is a member of the Scientific Council of the national Clinical Nutrition Certification Board and is on the board of directors of the Mid-American Health Organization (MAHO), the Midwest regional affiliate of the National Products Association (NPA). In July, 2008, Neil was named an NPA Industry Champion, "an award given to people who have made notable individual contributions to industry above and beyond what is expected to achieve commercial success".
Neil is the immediate past president and Program Chair of the American Nutrition Association (americannutritionassociation.org).
Neil is frequently published or quoted in magazines, newspapers, and scientific journals and has been on numerous radio and television news programs. Follow me on Twitter: neilelevin